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临床试验/NCT02283528
NCT02283528已完成不适用

A Comparison of Stryker Hybrid Arch Bars Versus Erich Arch Bars for Maxillomandibular Fixation of Mandibular Fractures: A Prospective Randomized Study

Emory University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Time to Place Archbars

研究概览

简要总结

Patients who sustain a fracture of the lower jaw are typically treated by wiring the teeth together or using small titanium plates and screws to fix the fracture. With either technique the upper and lower teeth are held together to ensure that the fracture is held in the correct position during healing (for closed reduction) or while the plate and screws are applied (for open reduction).

The teeth can be held together using Erich arch bars which are a type of braces that are temporarily wired to the existing teeth. These stay in place for 6 weeks until the fracture has healed even though the patient is able to open his mouth immediately after the surgery is complete. The alternative to the traditional Erich arch bars is a relatively new type of arch bar (Stryker Hybrid) that is screwed to the jaw bone rather than wired to the teeth. The purpose of this study is to compare the two types of arch bars in terms of the speed with which they can be applied as well as any difference in fracture healing

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Mandible fracture involving subcondyle, ramus, angle, body, parasymphysis and symphysis
  • Age 18 years - 90 years
  • Ability to give informed consent
  • Minimum 6 weeks follow-up
  • Pre and post-operative panoramic xrays

排除标准

  • Comminuted fractures
  • Infected fractures
  • Previously treated fractures
  • Complete edentulism
  • Gun shot wounds
  • Pregnancy or breast feeding

结局指标

主要结局

Time to Place Archbars

时间窗: During initial admission and surgery

Time taken to place archbars

次要结局

  • Number of Participants With Complications Including Loosening of Archbars, Loosening of MMF, or Damage to Adjacent Teeth and Structures(up to 6 weeks post operatively)
  • Number of Participants With Fracture Healing at 6 Weeks(6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gary F Bouloux MD, DDS, MDSc, FRACDS, FRACDS

Associate Professor

Emory University

研究点 (1)

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